How do we get involved? I have an early-stage drug development model powered by IT and software systems to advance drugs from the bench to the market

2:45 pm December 9, 2010

Biotech entrepreneur wrote :

It is laughable to suggest that the NIH is going to have a speed advantage over industry. It takes them eighteen months just to make a decision about what to invest in (review a grant). This is a government bureaucracy! Academics should not be trying to reinvent the wheel. If you want to invest government money in progressing innovative drug development, give grants to innovative biotech companies that are starved of funding but full of know-how.

8:34 am December 13, 2010

virtual biotech CEO wrote :

It is a joke, and a waste of taxpayers money. An inefficient, slow gov machinery trying to rescue failing sector of the industry. Big pharma companies have been destroying the value of scientific discoveries for a long time now. Yet, characterically the initiative will "kick-off" with NIH meeting with pharma. I can see this meeting - a political nightmare of conflicting interests of separate companies. So it will continue. I could not agree more with the previous comment - if you are serious about it - create small, virtual projects around promising assets where most of the money will go to moving projects ahead.

11:06 am December 14, 2010

PhDCEO wrote :

NIH is not trying to 'compete' with industry (although this would benefit Pharma, as they would actually look good next to the NIH). The issue they are addressing is the increasing gap between basic research and commercial development. You can't simply issue grants to nascent biotech companies and hope to solve this problem. First, the granting cycle is not conducive to fast-paced innovation, and second, the grants would have to be enormous to hold any real value. I think this is a key piece of the equation that can only be addressed by an agency like the NIH. There are many other pieces that need to be addressed, by academia, biopharma, and investors, but definitely a step in the right direction.

2:14 pm January 23, 2011

student1776 wrote :

To introduce some facts into the discussion:
1. Broadly speaking the pharmaceutical industry sells $800B in product globally and invests $140B a year in research and development - $45B in drug discovery and $95B in clinical costs.
2. The more drugs they sell the more money they spend on R&D - about 16% on average - the highest of any industry in existence by far (more than electronics or defense etc). The industry pays far more in R&D than it does in bonuses or dividends etc.
3. In the US we have a rapacious generics industry. Once a drug goes off patent the generics industries sell it at near cost and the profit essentially disappears. The good thing is that prices go down. The bad thing is that the profit pays for the new drugs.
4. The modern industry began around 1800 with the smallpox vaccine (1798) and the first modern small molecule drug (morphine 1806). In the 200 years since the industry started the proliferation of new drugs, devices, biologicals, vaccines and diagnostics has made modern medicine and public health possible and has increased the average human lifespan from 20-25 to 80 - giving the average person about 50 years more life to life.
5. For the last decade the average number of new drugs approved for sale has dropped to about 25 (down from about 45 in the 1990s) while the number of drugs going off patent has been about 35. Basically this is incompatible for life for the industry. The industry responded by quadrupling R&D but the FDA, frightened by politicians, has raised the obstacles to approval so high that it is almost impossible to get a drug approved - vastly raising the cost per new drug and requiring higher prices to break even.
6. In the US our healthcare system is more expensive than other countries (about 15% of GD compared to about 10% of GDP in most other OECD major countries) BUT the cost of pharmaceutical is THE SAME as in other OECD countries - for example pharmaceuticals are about 1.1% of GDP in the US and about 1.3% of GDP in France. There is a difference in the pricing system. In the US because of our rapacious generics industry virtually all the profit to pay for the companies (price drops 90%) that create the new pharmaceuticals has to come from the years when a drug is on patent - resulting in prices about 2X the cost in the EU - BUT when it goes generic the cost is much lower. In contrast in the EU and Japan the money paid up front when a drug is on patent is half that of the US but the lack of an aggressive generics industry means that the prices remain at about 50-75% of the original half of the US price for a decade. Overall the total cost for the drug is the same. The US system forces continued innovation, creation of new products - the reason that Pharma has become overwhelmingly a US based industry. The EU system basically encourages companies to keep nursing along the same old drugs and spend less on developing new drugs.
7. 90% of the costs of the US healthcare systems have nothing to do with the costs of drugs. It comes from paying for beautiful hospitals and offices, doctors and nurses. The reality is that two things get you better - either nature heals you or the therapeutics (or surgeon) heal you. Doctors and nurses are essential to make the diagnosis and keep you alive while nature or drugs get you better but the thing under mankind's control that gets you better are the drugs. When you kill the system that creates the new drugs what you basically do is freeze the system into the current cost structure. To drive the point home - if you completely killed the pharma industry, nationalized every plant, made the executives and workers slaves and produced all the drugs, devices etc at cost you would lower healthcare costs about 10% for one year at the price of eliminating the possibility of any better more effective treatments that would lower future costs - meanwhile the cost inflation of the rest of the healthcare system would continue to raise at its current 8%/year rate. Think of the way that the polio vaccine eliminated the hospitals with thousands of iron lungs. This would end
8. Last, this new government bureaucracy is a drop in the bucket to be conducted by amateurs who have no sense or history of urgency. Nothing will come of it other than, hopefully, if someday they come up with something interesting they will find out how the FDA is a prison-house for new therapeutics - keeping them shackled in the dark. If an FDAer approves a drug and then someday something unexpectedly bad about it surfaces they get in trouble. If they don't approve a drug and millions die for the lack of it, nobody ever hears about it and they pay no career price - and instead get promoted by the bureaucracy. The government has a strong disincentive to approving any drug, no matter how beneficial.

Sorry for the long email but I thought the discussion would benefit from some facts.

8:26 am January 25, 2011

Academic Drug Discovery Researcher wrote :

Another issue raised by this event is the impact that the move will have on academic research. In response to the pharmaceutical industry's loss of interest in basic and early drug discovery research, many universities have started drug discovery initiatives to help fill the gap. As a result of the recent glut of American pharmaceutical company layoffs (60,000 in 2009; 53000 in 2010), many of these new efforts are driven and staffed by seasoned, experienced industrial drug discovery scientists that know how to do drug discovery. Their research is funded by grants, not with a Congress-bestowed budget like the proposed NCATS. Even though the official "party line" is that there are no immediate plans to cannabalize the budgets of other NIH components to support the NCATS (http://feedback.nih.gov/index.php/ncats), it is only a matter of time before Congress starts looking for ways to cut costs, and will likely wonder why they are supporting academic research when the NIH has its own multi-million dollar "drug discovery" institute. One of the common missions of academic drug discovery groups is to help academic scientists develop their ideas and new biological targets into drug discovery projects that pharmaceutical companies would consider licensing, in essence doing the basic research and early drug discovery/translational work needed to make the target appealing to a company foacused on commercial development. The merit of the academic drug discovery concept is that it taps into an unexploited source of ideas, those of academic researchers, and provides translational support for their potential development. Care must be taken to prevent the inevitable expanding budget of the NCATS from eating into the NIH's ever shrinking research funding budget. The "no plans for cannabalism" of today may not hold for tomorrow.

12:10 pm January 25, 2011

RN wrote :

Not such a bad idea. It is time NIH thinks outside the usual route of granting cycles and Investigator initiated grants. If having a drug discovery inst. within NIH means competition with industry, it does not hurt. Industry ought to like this idea. This concept however, requires careful planning. By focusing on orphan drugs and drugs that have gone through the clinical trails, but failed due to toxicity etc., one can move valuable leads much closer to the bed side. I am excited with the idea.

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